As part of Parexel Consulting, you will create and maximize value for clients throughout the product lifecycle. You will be a strategic guide in getting products to market faster, smarter – and keeping them there –your scientific, technical, regulatory, and/or commercial expertise will put best practice standards to work for biopharmaceutical and medical device companies large and small.
In return, you will be provided with interesting opportunities for growth and development and exposed to a variety of challenging assignments, product types, geographic regions, and therapeutic areas. Plus, as member of Parexel Consulting, you will enjoy all the advantages of working remotely, combined with access to the mentorship from a team of highly experienced regulatory professionals at the height of their careers. Join our team, and you will design solutions for the complexities of an ever-changing global marketplace.
- Full Time
- Level: Mid
- Travel: Yes
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Success Profile
Check out the top traits we're looking for and see if you have the right mix.
- Detail-Oriented
- Proactive
- Problem-Solver
- Results-Driven
- Organized
- Multi-Tasker
Rewards
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Global Impact
We are one truly global team working together to propel each client´s journey ahead faster.
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Balance
We value work-life balance. We try and keep regular hours and an emphasis on life outside the office.
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Collaboration
Work with industry leaders and subject matter experts.
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Freedom
The ability to innovate, ask “what if” and try new solutions without fear of failure.
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Variety
Opportunities to work on multiple accounts – never boring!
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Management
Strong management with depth of experience working for global health authorities.
Responsibilities
As a Regulatory Affairs Associate you will be responsible for specified product portfolio. This product responsibility includes both
national and central licenses and also projects still in development. You will act as a Subject Matter Expert and/or Key User for one or several expert areas within regulatory department.
Be the regulatory expert providing regulatory expertise on the assigned product portfolio in cross-functional settings to support the business.
Job Responsibilities:
· Prepare and submit relevant regulatory submissions of high quality and in compliance with local regulatory requirements, in a timely manner.
· Ensure effective interaction with authorities to support local/central functions for assigned activities. Respond to questions from the authority in collaboration with the Headquarter.
· Ensure local labelling (SmPC, PIL, pack-label and compendium) are updated and consistent and comply with local regulatory requirements.
· Ensure pack artwork is updated according to local legislation and internal processes.
· Ensure local translations of high quality that are agreed with internal partners, according to SOP, and delivered according to timelines.
· Initiate update of the regulatory databases in a timely/regular manner to ensure compliance.
· Keep fully aware of local and EU regulatory requirements and Internal Regulatory Processes and Policies
· Build/maintain local/central and external relationships to support assigned product portfolio and expert area.
· Provide regulatory input (also including environmental aspects) to the tender process (where applicable) for assigned portfolio.
· Participate in central project groups, when relevant, to ensure an optimal regulatory strategy is implemented.
· Work with supply and business to mitigate consequences of stock-out situations.
· Represent regulatory function in cross-functional teams
· Participate in SOP maintenance and management monitoring activities as necessary.
Knowledge, competence and skills
· University degree in a scientific area
· Initial years of Regulatory Affairs experience
· Good attention to details
· Able to take responsibility and provide leadership
· Collaborative approach and enjoy working in a team
· Able to influence and to liaise with internal and external stakeholders
· Understands both business content and issues in the external environment
· Fluent in English and local language
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